Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Connections App.
- Who it may be relevant to
- Registry conditions: Alcohol Use Disorder, Alcohol-related Liver Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease (IMPACT-ALD): Aim 1
Overview
This protocol describes a randomized controlled trial testing the effectiveness and implementability of the CHESS Health Connections smartphone application among patients with alcohol-associated liver disease (ALD) at two medical centers in Michigan and Wisconsin, in two types of clinics: general hepatology and multidisciplinary that offers care for advanced ALD alongside co-located, integrated mental health and substance abuse treatment. The long-term goal of this and future work is to prevent disease progression and promote healthy behaviors by improving the rate of abstinence among patients with ALD earlier in the course of their disease. 298 participants will be enrolled and can expect to be on study for up to 6 months.
Detailed description
The goal of this project is to implement and evaluate an evidence-based mHealth system to help patients diagnosed with ALD with alcohol cessation. Connections is a mobile health app developed by CHESS Health to support patients with alcohol use disorders. Patients will be enrolled in both general hepatology and multidisciplinary ALD clinics (which include integrated alcohol use treatment professionals alongside hepatology providers) at two large tertiary care centers (University of Wisconsin (UW) and University of Michigan (UM)). The hypothesis is that the implementation of an adapted version of Connections for patients with ALD will improve rates of alcohol cessation and improve liver function.
* Aim 1 (described in this record) will assess the effectiveness of the Connections app plus usual care (n=149) compared to usual care (n=149) on days of alcohol abstinence over 6 months. * Aim 2: Assess the implementability of the Connections app in the ALD population using the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) to determine facilitators and barriers to the successful adoption of the app at the patient, provider, and clinic levels.
Secondary analyses will examine use of the Connections app on health outcomes (including depression, anxiety, insomnia, liver health, and quality of life) and health behaviors (including engagement with alcohol use disorder (AUD) and/or ALD treatments and ongoing alcohol use). Key moderators (including age, sex, race, ethnicity, marital status, rurality, and ALD severity) and mediators (including relatedness, competence, autonomous motivation) on outcomes will be explored. The impact of the Connections app on measures of chronic liver impairment documented in the health record will be examined.
Interventions
- Device Connections App
mobile application, a place where participants can find community and support to help them manage their ALD, learn liver health self-care, coping skills, and alcohol abstinence strategies.
Primary outcome measures
- Days of Alcohol Abstinence in ALD Participants [Time frame: data collected monthly, up to 6 months]
- Number of Standard Drinks Consumed in ALD Participants [Time frame: data collected monthly, up to 6 months]
Secondary outcome measures (11)
- Change in Patient Health Questionnaire (PHQ-8) Score [Time frame: baseline, 3 months, 6 months]
- Change in PROMIS Global Health Score [Time frame: baseline, 3 months, 6 months]
- Change in Generalized Anxiety Disorder (GAD-7) Score [Time frame: baseline, 3 months, 6 months]
- Change in Insomnia Severity Index (ISI) Score [Time frame: baseline, 3 months, 6 months]
- Change in Pain Interference (PEG) Score [Time frame: baseline, 3 months, 6 months]
- Change in Drinking Motivations Questionnaire - Adult (DMQ-A) Score [Time frame: baseline, 3 months, 6 months]
- Change in CHESS Bonding Scale Score [Time frame: baseline, 3 months, 6 months]
- Change in Drug-Taking Confidence Questionnaire (DTCQ-8A) Score [Time frame: baseline, 3 months, 6 months]
- Change in Treatment Self-Regulation Questionnaire (TSRQ) Score [Time frame: baseline, 3 months, 6 months]
- Alcohol Use Disorders Identification Test (AUDIT-10) [Time frame: baseline, 6 months]
- CHESS Bonding Scale [Time frame: baseline, 3 months, 6 months]
Eligibility criteria
Inclusion Criteria (Aim 1):
- Diagnosis of ALD (any stage)
- Alcoholic liver disease (ALD) encompasses a spectrum of hepatic injuries caused by long-term alcohol abuse. For this study, participants will have a diagnosis of ALD or evidence of the combination of liver disease and alcohol misuse in electronic health record.
- Alcohol use within the last 6 months
- Receiving care at UW or Henry Ford Health + MSU
- Either the general hepatology clinic or the multidisciplinary ALD clinic
- Able to read and write proficiently in English
- Willing and able to use a smartphone app
Exclusion criteria
- Actively listed for liver transplant or history of liver transplant before being enrolled in the study. Participants added to a liver transplant list after being enrolled in the study will be allowed to continue their participation
- In hospice care
- Has severe cognitive impairment (as described in electronic health record including dementia, delirium, and/or unable to maintain cognitive alertness during screening--as determined by study staff.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 3 centers
- Henry Ford + Michigan State University Health Center — Lansing
- UW General Hepatology Clinic — Madison
- UW Multidisciplinary ALD Clinic — Madison
Identifiers
NCT: NCT06305624 · 2024-0130 · 1R01AA030470-01A1 · A532000 · Protocol Version 4/23/26